JS016注射液用0.9%氯化钠注射液(100ml)稀释至不同浓度,然后稀释后的注射液被在室温下放置0和2小时,接触输液器滴注0小时、3小时的英语翻译

JS016注射液用0.9%氯化钠注射液(100ml)稀释至不同浓度,然

JS016注射液用0.9%氯化钠注射液(100ml)稀释至不同浓度,然后稀释后的注射液被在室温下放置0和2小时,接触输液器滴注0小时、3小时和6小时室温放置后取样检测,测得的JS016不溶性微粒(光阻法和MFI)、外观和可见异物(灯检法)、蛋白质含量(紫外分光光度法)、pH、纯度(SEC-HPLC)和生物学活性(结合ELISA法)均符合预期的质量标准。
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结果 (英语) 1: [复制]
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JS016 injection is diluted with 0.9% sodium chloride injection (100ml) to different concentrations, and then the diluted injection is placed at room temperature for 0 and 2 hours, and the infusion is instilled for 0 hours, 3 hours and 6 hours at room temperature. After sampling and testing, the measured JS016 insoluble particles (photoresistance method and MFI), appearance and visible foreign matter (lamp inspection method), protein content (UV spectrophotometry), pH, purity (SEC-HPLC) and biological activity ( Combined with ELISA method) all meet the expected quality standards.
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结果 (英语) 2:[复制]
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JS016 injection with 0.9% sodium chloride injection (100ml) diluted to different concentrations, then diluted injections are placed at room temperature for 0 and 2 hours, contact infusion drip 0 hours, 3 hours and 6 hours after room temperature sampling test, measured JS016 insoluble particles (light resistance and MFI), appearance and visible isometric ( exoscope), protein content (exomeliometric), exome, opiental light Purity (SEC-HPLC) and biological activity (combined with the ELISA method) meet the expected quality standards.
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结果 (英语) 3:[复制]
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Js016 injection was diluted with 0.9% sodium chloride injection (100ml) to different concentrations. Then the diluted injection was placed at room temperature for 0 and 2 hours. Contact with the infusion set for drip infusion for 0, 3 and 6 hours, samples were taken after placing at room temperature. Js016 insoluble particles (light resistance method and MFI), appearance and visible foreign matter (lamp detection method) and protein content (UV spectrophotometry) were measured The results showed that, pH, purity (SEC-HPLC) and biological activity (combined with ELISA) met the expected quality standards.<br>
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